U.S. Institute of Medicine Study Urges New Approach to Regulating Supplements – Big Pharma Influenced Doctors Get it Wrong Again
May 18, 2010
The U.S. Institute of Medicine represents the heart of the medical establishment. Congress listens to it. The President listens to it. The FDA listens to it.
In this case, the FDA’s Center for Food Safety and Applied Nutrition posed some technical questions to the Institute of Medicine. Please note that this FDA center is in charge of regulating dietary supplements. Unfortunately the Institute of Medicine decided to go beyond the technical questions posed and instead chose to recommend a new approach to regulating supplements. A lot of what the IOM said was wrong, but let’s take it from the top. View the report here.
1) The IOM seems to think that healthy foods and supplements should be regulated like drugs. “There is no scientific rationale for having different levels of rigor applied to these different categories,” said Dr. John Ball, chair of the committee that produced the report.
Really? The distinguished scientists on the IOM panel should be able to understand that natural products cannot be patented and therefore cannot be brought through the obscenely expensive FDA approval process required for drugs. Who does the IOM or FDA expect to pay a billion dollar cost of approval for cherries or walnuts? Individual cherry or walnut growers? Will consumers buy cherries if they cost as much as drugs?
This is what we have called the Catch 22 of contemporary American medicine.
Because only non-natural and patentable substances can be brought through the FDA approval process, the FDA in effect enforces a medical monopoly for drug companies. As a direct consequence, natural and often much safer and cheaper natural remedies are ignored. Natural medicine based on diet, dietary supplements, and lifestyle, which ought to be at the center of medicine, are shunted off to the sidelines and subjected to legal threats by hostile regulatory agencies.
By the way, how safe are all those drugs that go through the FDA approval process? In 2008, the FDA received more than 530,000 reports of suspected adverse drug effect, there were 320,000 serious adverse events and nearly 50,000 deaths reported. A report in 2007 by the FDA, CDC and U.S. Consumer Product Safety Commission found that common drug dangers are so bad that “Harmful reactions to some of the most widely used medicines – from insulin to a common antibiotic – send more than 700,000 Americans to emergency rooms each year.” View the report here.
2) The IOM also seems to favor strengthening FDA authority over supplements and allowing the agency to pull supplements because of vague concerns, not just the current standard of “significant or unreasonable risk.” The report cites a study on beta-carotene as partial justification for this, but clearly hasn’t bothered to look into the seriously flawed science behind the study. This recommendation again misses the central point: it would be nice to pay for a billion dollars of study of each component of our diet but who will pay for this? Medical costs are already completely unsustainable and food prices are rising. Do we really want to regulate functional foods and supplements out of existence? The drug companies of course would like that very much—no more competition.
3) IOM also doesn’t like the idea that a supplement intended for bones (containing vitamin K, D, calcium, and other minerals) may currently cite accepted claims for vitamin D or calcium. No. The IOM committee thinks that the entire product in each case should be required to be researched as a whole and nothing whatever said about component vitamin D or calcium benefits. Never mind that the report also says that “in order to make informed decisions individuals need access to complete information.” How is the public to get any information, much less complete information, with these irrational government gag orders in place?
ANH-USA has a guess about what is bothering the distinguished committee members. None of us like to see sugary cereal makers claiming health benefits for their cereals because they have sprayed on a few cheap synthetic vitamins. But let’s not throw out the baby with the bath water. Let’s have a little common sense. The bone product should be able to cite the vitamin D claim. Otherwise the purchaser is left in the dark. And the cereal maker should be required to be honest about what else is in the cereal.
4) The report says that its recommendations are “consistent with recent efforts to improve the use of science at FDA and in European Regulatory Agencies.” The bare truth (as pointed out by ANH-Intl’s Dr. Rob Verkerk in a series of peer reviewed scientific journal articles) is that the science used by the European Regulatory Agencies is very poor science and is getting worse, not better.
5) The IOM report makes some good points too. For example, it notes that the FDA relies heavily on so-called bio-markers in approving drugs and there isn’t enough or consistent science behind this. For example, it is taken almost on faith today that a cholesterol lowering drug (cholesterol is the bio-marker) will reduce heart disease and lengthen life. This is naïve: cholesterol is not an illness in itself; indeed we cannot live without it. And the drugs used to reduce cholesterol are quite dangerous. Similarly reduction of blood pressure (a bio-marker) is assumed to be “good” without considering the side effects of the drugs that produce it.
We agree that bio-markers are being misused at the FDA. But that does not mean that drugs and supplements should be subjected to identical research requirements.
In general, we must always be wary when conventional medicine calls for greater scientific “consistency.” That is often just an excuse for choosing some valid science and excluding some other, equally valid science for ideological reasons.
For example, did you know that the phrase “evidence based medicine,” as used by conventional medical research, means accepting the kind of human trials currently demanded by the FDA and rejecting all other forms of scientific evidence? This is true even though food in particular cannot be studied in the same way as a drug. It has multiple ingredients and effects which interact with other multiple ingredients and effects in ways that cannot possibly be isolated.
There are rumors on Capitol Hill that an upcoming Congressional hearing will address the supplement issues raised by this poorly thought through IOM report. We have our ear to the ground and will keep you informed as we learn more.
I have a rare genetic disorder that results in the stripping of zinc and B6 from my body. The only way I can be functional is to take 5,000x the recommended daily amount of B6 and 7x the recommended daily amount of zinc. Without it I am debilitated (and was for years before receiving having been correctly diagnosed, which was the result of my own research; no doctor or practitioner had been able to figure out what caused my chronic debility). The FDA has already taken the most common form of vitamin B6 off the market and given it to a drug company for its sole proprietary use. They did the same with the weakest and safest bioidentical hormone used for hormone replacement, estriole. There is talk that omega 3 fatty acids may be next (this from my optometrist). My life depends on my access to unadulterated supplements. It could easily be sacrificed to the greed of pharmaceutical companies and the corruption of an agency of the our government. And of course we pay the taxes that support this corruption.
This can all be summed up in one word, ‘GREED’…
I spent 15 years fighting a serious illness that my American-trained Internal Medicine MD fought with lots of expensive drugs, which only made me worse, and with a diagnosis that changed almost yearly but mostly meant that, TO HIM, my problems were mental and therefore not serious enough to warrant any real testing. When I got to the point where my life was not good enough to continue living, I found an alternative doctor who could actually do a real diagnostic exam and focused testing using high-tech laboratories, instead of the lousy testing I got from mainstream labs, and guess what? That doctor actually found that I was suffering from five serious infective diseases that my AMA doctor never even thought to investigate. After two years on nothing but an organic, high quality diet, supplements, herbal preparations and natural antibiotics I am completely cured, even of some problems I was not even aware I had. And all this at a mere fraction of the $$$ I was spending on AMA medicine, which, by the way, I will NEVER EVER return to and, therefore, I have this to say about the FDA. GET RID OF IT! They do NOTHING FOR THE AMERICAN PEOPLE!! This agency is actually a PROPAGANDA ARM OF OUR REPRESSIVE GOVERNMENT AND THE CORPORATIONS WHO KEEP IT IN POWER!
I am using vitamins minerals and herbs to “CURE” my PAD. The first thing the alternative doctor I went to see(who just switched over to alternative) did was prescribe STATIN DRUG and BLOOD PRESSURE DRUG. Both I refused to do and in fact switched to another doctor at the same place. My BLOOD PRESSURE is now 123/78 from highs of 160/100. I did this naturally with no DRUGS. Now for the FDA(which hates natural healing) to take over and control supplements is just crazy. Like other posts on this they OK drugs with side effects of DEATH – STROKE – HEART ATTACK but want ot limit my access to natural products that do actually “CURE”. Just remember in November to VOTE against more government take over of everything. The DEM that just won the special election for MUrtha’s old seat appears to be OK as far as DEMs go. He is not a follower of Pelosi and Reed and Obama. So there are some DEMs that are getting the message.
I do not trust the corporate mentality management at the FDA. For them it is more about profits for their corporate alliances (drug companies, food conglomerates) rather than for the good of the public. True, as stated in the article that I have written this response to, there are concerns that must be dealt with (GMO’s, untruthful labeling), but true scientific response and transparency from FDA management? Well, I find it very questionable, what with their past record and M.O. FDA and congress go to work with the present rules and regulations on the books to correct the present ills and stay out of my supplement and food supply.
Thank you for supp;yig such important information. We need to get this kind of info into mainstream media. Most people have no idea of what is happening or the impact it will have on our current and future food, health and nutrition.
We shall fight you in the streets…we shall fight you in the trenches. We must not let these idiots take control of vitamins and supplements! Let your representatives know that you WILL NOT stand by and let this happen!!
This has nothing to do with public safety nor public benefits. It is about governmental control of individuals. Medical students receive no classes on nutrition nor alternative drugs. My fishing buddy is a doctir and a great guy. I asked him once, “if he had ever had a class in medical school on nutrition or alternative medicine”? He said that, “one Saturday morning they had a non-mandatory meeting on nutrition, but he was too tired to go”. Medical Practioners say that alternative medicine is a farce and a scam that one cannot derive any benefits from. So why would they want the FDA to regulate them. Because “Big Pharma” has made lap dog whores out of the general medical community. The general public is waking up to this fact, and are starting to realize that alternative medicine (vitamins, minerals, and natural foods) works. Additionally, it works for substantially less dollars than those from “Big Pharma”. The pharmaceutical mafia is on the warpath, not because they give to hoots in hell for the general public, but because they cannot garner any profit from it.
Wake up America!
Why don’t they just leave human beings and supplements alone and work on something truly worthwhile — like improving both the safety and efficacy of the drugs they approve.
Please…………don’t let the government step in once again and try to force us to give up our supplements. They have no right sticking their noses in our private business. I have been forced in the past to take pharmaceuticals and they put me in the hospital. I was told not to take certain ones and yet my doctor insists I get back on them. Shes been brain washed and she also gets kickbacks for the drugs she perscribes. I have permanent kidney and liver damage from them and refuse to take them. I’m now in the process of looking for another doctor. I have found that by taking the natural supplements, I feel far better than being drugged up. Our government has their hands into too many things and regulates far too many . They no longer listen to the American people. They blackball or fine any doctors that try to tell you about good and natural things. Did you ever hear them talk about a cure for any disease???? No, thats because there is far too much money to be made by the pharmaceuticals to treat and not cure.
It’s time we woke up and took back control of OUR goverment. I’ll be watching on the next elections and picking my choices by which individual that will work FOR THE PEOPLE.
Healthy food and herbs and supplements work — drug company medicines are poison.
I cannot take any of them —
This is crazy, how can they justify this??
Please leave our food, vitamins and supplements alone. We do not need any regulations. We should be free to chose taking them without any advise and surcharge from the government. You already have enough profits derived from drug companies.
Please keep an eye on these crooks.
adjunctive medicine
It dont matter how we are being abused by the ‘ F . D . A . ” as long as they make million’s upon million’s selling medicine that they know might ” K I L L ” THEY HIDE IT . BUT A LOT OF TIMES LATELY THEY GET CAUGHT !!!!!!!!!!!!!!!!!!! They don’t careif we die from medicine that has a lot of side effect’s ! How come the pharmacutical co’s gave ‘ M A C A I N I A C 200,000 THOUSAND DOLLARS WHEN HE WAS RUNNING FOR PRESIDENT !! THANK THE LORD NE DIDN’T MAKE !IF HE TOOK NUTRIENT’S HE WOULD CHANGE FROM LOOKING LIKE A D R U N K TO A HUMAN BEING !!!!!!!!!!
Recently I wrote to one of my congress-people saying that if the present course is not altered, carrots will be made illegal because they contain carotene, Now I see that what I thought was a far-out joke is neither. Have we passed the tipping point?
Your link to USPharmacist.com about 2008 adverse events doesn’t work. This link seems OK:
http://uspharmacist.com/content/t/miscellaneous,otc_medications/c/20262/
what on earth will be next; they are like flies on s*** to get suppliments gone. what the hell. I am so so so so sick of this, and there retarded efforts to make our food supply crap. these people are beyond evil these power elite make me sick. I pray to god every night to come and help the good people we need serious backup, it seems like they- the evil ones complicit in our demise, out number the good/awake people of our planet, for godsake w/ out decent food nutrition we have nothing and they win end game- i guess that is why they are so hot after the afore mentioned items suppliments/ food!! O ya and they get money and power for selling out. Are they so dumb that they don’t get the fact that after this life what they face should scare the shit out of them? O ya they believe the great deciever that they will be able to take it w/ them hum i bet that is what they think!!!!! Idiots all of them.
The FDA’s Center for Food Safety and Applied Nutrition posed some technical questions to the Institute of Medicine. Unfortunately the Institute of Medicine decided to go beyond the technical questions posed and instead chose to recommend a new approach to regulating supplements. I am strongly opposed to “fixing” something which isn’t broken. Leave my supplements alone!!
It is obscene and truly disgusting that the medical profession is challenging what i consider to be too many restrictions on supplements already! We know it’s only about the money, and that infuriates me. And with more regulation, would that mean the dollars i spend on supplements would be tax deductible, like other medicines???
It’s just more socialism and control over everything we do.
and shows their hypocrisy on one hand saying they want to reduce health care cost, and then on the other hand, deliberately making sure that we remain unhealthy as anything healthy will be too expensive or even not available. one can but shake ones head at the utter stupidity, unless there really is a sinister agenda behind it. more likely the latter…..
I pray that some common sense, honesty and integrety become a part of the decisions made concerning natural health.I vote for natural supplements and alternative medicine that go to the problem and heal our illnesses, not drugs that only mask symptons and never heal anything.
How can they do this when they can’t keep track of the very pharmaceuticals they prescribe and the deadly side effects that occur? Ridiculous!
Why is the fox guarding the hen house? The US Institute of Medicine has not answered the question it was answered but instead is taking away freedom from individuals who DO NOT WANT TO USE DRUGS AND WESTERN MEDICINE.
FOOD AND SUPPLEMENTS are NOT drugs. They are natural and help us get wellness. Take off blinders of western medicine and look through the eyes of quantum physics and energy medicine and rule from that perspective, or at least balance western and alternative medicine.
We don’t want the drug mafia to run our lives…nor the MDs. We want to have options that support empowerment and wellness, not sickness and submission to their authority.
Apparently those who don’t know are given the authority to force what they don’t know on us…and of course, the reasons for that are ignorance, greed, power and just plain stupidity.
Should we not base important decisions on facts backed by experience and thus, true knowledge, and applied by people with the knowledge and experience to do so wisely?
Big Pharma needs to stay away from our vitamins, minerals and supplements. Back off. Stick to your drugs and stay away from what we the people want to put in our bodies as alteranatives to your drugs which end up having worse side effects than what they cure.
thank you for the very intelligent thought process and insights. i am very disturbed by the political and economic rationale for decisions on legislation. please continue your very thorough work to inform and develop support for citizen based decisions. the medicalization of our society again makes us the victims of commercial excess. citizens soon know when a product works or fails regardless of the claims. our faith in prescriptions is falling and the credibility of medical profession is weakened by increased mercenary motivations. greed seems to be the primary motivation for everything that everyone does. let’s build trust & confidence & competence in our conduct!!…
grandpa george
The phrase “evidence based medicine,” as used by conventional medical research, means accepting the kind of human trials currently demanded by the FDA and rejecting all other forms of scientific evidence. This is true even though food in particular cannot be studied in the same way as a drug. It has multiple ingredients and effects which interact with other multiple ingredients and effects in ways that cannot possibly be isolated.
Bio-markers are being misused at the FDA. But that does not mean that drugs and supplements should be subjected to identical research requirements.
This is all about money and power. Medicine and the government want to control everything, taking away our freedom to eat what we want and get healthy the way we want, not the way Medicine, big Pharmaceuticals and the FDA want us to. They want us to be sick and dependent upon them.
Here comes the medical profession (drug companies) once again, trying to knock out anything healthful so people can get sick and then only have their dangerous and rather deadly drugs to rely on. In other words, don’t get to the cure; only treat the symptoms and do thatforever, or as long as the person can live with all the deadly side-effects from treating the symptoms only. Very sad state of affairs in this country, with a government that is bought and sold by the drug companies. I wouldn’t want those folks’ karma!
I am a person in favor of holistic health care and preventative alternatives. I enjoy eating right ie. fruits and vegetables, nuts and the use of supplements. I truly believe that supplements are safe and that drugs are not safe for my use and consumption. What is this country coming to? God created all the food that grows and the animals for our use and consumption. I don’t trust anything that man makes and manufactures for my consumption. What’s next, soylent green?
It is not true that “natural products cannot be patented”. While a natural compound may not be patentable since it lacks novelty under 35 USC 102, and here the term “compound” is used in its strict chemical meaning, a substance having a definite atomic and/or molecular composition, for example, H20, water, it is possible to patent a composition of matter comprising two or more
naturally occurring compounds if it can be shown that the mixture has synergetic properties or unexpected properties, properties that are more that expected from the added effect of the properties of the individual compounds.
Regarding the FDA, I believe that those submitting new medicines requiring clinical testing carry the burden of proof of efficacy and lack of harmful effects by swearing under oath that the data and testing results are true under penalty of a severe fine or the like as is called for by the Patent Laws and Rules of Practice, 35 USC and 37CFR.
How do we get these cockroaches out of our food?
As usual, these hacks and quacks are back at work trying to regulate everything we eat, drink, hear, smell and taste. Throw all these bums in the gutter where they can learn some respect for individual’s ability to manage their own affairs free of onerous regulations.
“I will not attack your doctrines nor your creeds if they accord liberty to me. If they hold thought to be dangerous – if they aver that doubt is a crime, then I attack them one and all, because they enslave the minds of men.” – Robert Green Ingersoll
The distinguished scientists on the IOM panel should be able to understand that natural products cannot be patented and therefore cannot be brought through the obscenely expensive FDA approval process required for drugs. Who does the IOM or FDA expect to pay a billion dollar cost of approval for cherries or walnuts? Individual cherry or walnut growers? Will consumers buy cherries if they cost as much as drugs?
The manipulation by BIG PHARMA is obvious to all but those who see some personal gain. People truly want to make their own choices, certainly I do. My health is my responsibility; I don’t need BIG BROTHER to do more than to tell the truth. But truth is hard to come by when financial gain is at stake.
Lets keep food natural and free of poisons, toxins, additives, nano-particles, drugs, hormones, and other artificial manipulators.
Those who use natural supplements educated themselves about the products and care for their own health. Few doctors have any understanding of benefits of natural supplements. the majority of doctors only know how to prescribe medicines indiscriminately that have dileterious side effects. Tell govenment officiials not to support big pharma and not to take money fom pharma lobbists. Agin the blind and the corrupt are leading the blind and corrupt.
If I thought that the FDA could be honest and not money hungry to influence their meds rather than to help by allowing healthy supplements to be available, everyone would get on their bandwagon. However, it is apparent that once again the government and its lackies are trying to run amuck over citizens who take the time to check every ingredient and the source. FDA does not care about helping health, it only cares about the money. I say look to see who gets it and you might find out the agenda is not health but poisoning and death since so many meds have dangerous side effects and can ultimately challenge the health of all citizens. I say citizens should check out the companies, make sure they have legitimate research scientists who run tests not like the FDA and their excuse for vaccinations and the dangerous poisons that can cross over to many organs, brain, heart, liver, immune system and can eventually consume the welfare of this persons life versus giving health that promotes life rather than death. Wake up America you have let this organization determine who is smarter and it does not want you to take an interest in how you take care of your own health they want to dictate it to all including the children whose health will be compromised especially if they are vaccinated–who would ever think to connect the dots when a child has an episode in jr high or high school. Who would ever think it could be 99% the vaccination but no ones wants to mess with the FDA because they have too much power and like it that way.
Why can’t we get rid of the FDA and start over with people who know domething and care about something besides lining their pockets?
NO,NO..REGULATION ON SUPPLEMENTS..OR THIS COUNTRY WILL RESPOND IN A BIG WAY!
I am totally against this proposal because I do not want to put anything in my body that causes side effects because it it not natural. Tell Congressman Waxman who is also from Los Angeles to take to Big Pharma whose drugs are killing over 100,000 people every year. This is when they take the proper doses. This is infringing on my right to achieve better health through
natural means.
We need to Also, to include in the Health Reform Movement to allow insurance companies to offer coverage to supplements as well as prescription drugs. Of course, “This is too Much Like Right”
We need to protect our rights for better health by keeping this issue in the forefront.
expose Big Pharma for their corrupt practices that are causing harm to millions of Americans.
Our medical authorities seem to be mired in dark ages thinking: They cling to the mistake notion that they know better than do we ourselves what is reasonable and prudent. The number of deaths from approved substances attests clearly to this debacle. It looks suspiciously like they want to euthanize as many ordinaty people as can be covertly done. At least Kavokian worked with those who had no hope left…
totally agree with the above… but are you also sending it to the IOM, the FDA and the requisite lawmakers??? THAT’S critical stuff, as i can only do so much as an independent citizen, emailing varioius articles to those people who, if you’ll forgive my ‘french’, have their collective heads up their asses.
What else can one expect from the self-serving turds in organized medicine.
They are all in collusion with the criminals at the FDA (Fraud & Death Administration). These people are entirely incapable of moral/ethical behavior. They are all driven by desire for personal financial gain.
There is very little science in conventional medicine. It is a system based on authoritarian dogma designed to make it’s practitioners wealthy.
Prescription /OC drugs kill and sent to many to ER why they are allowed .Good nutrition keep
your immune system healthy.
Having come from 50+ years of natural foods, supplements, homeopathics and time honored use of herbal blends, not only for myself, my family and my fur family, this whole thing turns my stomach!
To me, this is just another way for the big drug companies to get rid of the competition of natural remedies.
It is most worthwhile to fight this possible regulation, but know that the drug companies, which are backing this wild demand, have more money at hand with which to do so. So it may be a David and Goliath battle!
As this critical evaluatiom of the IOM report makes clear, science gets a bad name when it is used to create an artificial monopoly using the sophistry that people must be as wary of “danger” from natural foods as they must be about often toxic prescription drugs that have a strong record of supposedly surprising side effects, that come to the fore when these drugs are prescribed for a mass market of people who were usually excluded from the clinical trials that supposedly “proved” a sufficient level of benefit over a placebo to gain approval.
This is all about controlling the population to the benefit of a few. Check out http://www.infowars.com and wake up! Get informed! Get involved! This can be stopped.
The pharmaceutical industry has KILLED my Mother and the the LOVE of my life. They have also almost killed many people I work with. They caused harm to my cousin, and almost KILLED my Father, but I became wise, and got him off most of the medications. The is a concerted effort to depopulate, and people do not understand that anyone can be so evil as to this concept, but believe me, it is happening. If someone would have told me this 5 years ago, I would have thought of they were crazy. I have learned from experience, and started doing my research. The contamination and/or ingredients in the drugs and vaccines are causing so many illnesses, including cancer, autoimmune diseases, and you name it. PLEASE DO THE RESEARCH!!!! Another good website is http://www.Mercola.com. I trust natural health websites, before I trust anything from the FDA, CDC, WHO, and all the other BIG INDUSTRIES that are so greedy and corrupt.
Leave my supplements alone! This is just another way for big pharmaceuticals to make money off people like myself who wont take their toxic pills.
I agree that supplements (and herbs) should be left alone. Big Pharma & the FDA are out of control.
Laws are passed that favor the few at the expense of the health of the many. Natural medicine including the use of supplements & herbs is a better approach, with much lower potential for dangerous side effects than mainstream drugs & surgery. Many drugs deemed “safe” by drug companies & the FDA are later found to be extreemly dangerous. Vioxx for example. Drugs are pushed by doctors, tv ads and the like, to everyone from babies to great grandmothers, for every possible percieved ailment. Ads often quote mile-long lists of potential side-effects. Those of us who choose to use natural health products should be able to do so. The freedom to choose how one cares for ones own body is a fundamental one that we must not lose.
“When the people allow the government to control the food they eat and the medicines they take, thier bodies will be in as sorry a state as those who live under tyranny.”